Quality Engineer
Are you a quality engineer looking for a new opportunity? Are you interested in joining the development process of medical device products for a fast scaling company?
Don't hesitate, and apply today
Overview:
Our client is seeking a Quality Engineer, supporting the quality assurance aspects of a manufacturing ramp-up. The successful candidate will provide essential quality oversight for production operations and relieve workload from the existing quality team.
This role is ideal for a quality professional who is proactive, detail-oriented, and confident in a cross-functional production setting.
Key Responsibilities:
- Provide quality support during the scale-up of production activities and station commissioning
- Collaborate with the manufacturing and quality teams to ensure adherence to regulatory and internal quality standards
- Investigate and document quality issues, including vendor deviations, operator/process errors, and equipment malfunctions
- Lead and support the execution of CAPAs, non-conformances, deviations, and associated investigations
- Maintain and improve quality documentation, protocols, and reports
- Support the qualification of new equipment and processes
Ideal Candidate:
- 2-3+ years of experience in a quality engineering role in MedTech, pharma, or biotech
- Solid knowledge of QA and regulatory requirements (e.g., ISO 13485, FDA QSR)
- Experience supporting production environments and working closely with operators, technicians, and engineers
- Excellent documentation and investigation/report writing skills
- Familiarity with electronic systems (e.g., firmware, software, hardware) used in production or devices - technical appreciation but not necessarily expertise
Location: Galway (hybrid on-site/remote as required)
Industry: Medical Device / Life Sciences